Regulatory Considerations for Body Heat Patch Manufacturers

Release time:2023-10-06    Click:127

Companies planning to produce body heat patches must comply with relevant regulations including:

01. OTC drug manufacturing standards

Follow GMP requirements for facilities, equipment, process controls, testing etc.

02. Biocompatibility testing

Evaluate skin sensitization according to ISO 10993 for clinical safety.

03. Ingredient testing

Analyze ingredient stability across expected shelf life per pharmacopeia guidelines.


04. Labeling laws

Include proper warnings, usage guidelines, active ingredients etc. on both primary and secondary packaging.

05. Regional regulatory approvals

File and obtain OTC drug approvals in target countries and regions before sale.

06. Post-marketing surveillance

Track and report adverse effects identified from customer feedback.

07. Quality systems

Implement ISO 13485, ISO 9001 systems for structured manufacturing control.

Staying current on applicable regulations and following design control processes ensures body heat patch product compliance before launch.